There is no “cloak of invisibility” for researchers.

FDA increases enforcement based on clinical research violations.  According to recently-posted data, 2014 was a banner year for FDA enforcement based on clinical research violations.  The Center for Drug Evaluation and Research (CDER) Office of Scientific Investigations issued 16 Warning Letters due to violations involving clinical trials, double the number from 2013.  Clinical Investigators received 11 of these, 3 went to sponsors, and one went to an Institutional Review Board (IRB).  FDA also issued 5 Notice of Initiation of Disqualification Proceedings letters to clinical investigators in 2014 (compared with none in 2013).  The number of inspections overseen by the Office of Scientific Inspections reached a 10-year high in 2014, up to 1007 from the 868 inspections in 2013.

There’s another reason that university researchers should be looking over their shoulders.  University researchers involved in product development should heed a recent Untitled Letter issued by the Office of Prescription Drug Promotion.  In late February, UCLA received an Untitled Letter  based on website statements FDA deemed to be unlawful preapproval promotion of an investigational drug.  The website touted the safety and effectiveness of an imaging agent being developed to assist in detecting traumatic brain injury.

Academics take note—partnerships for product development mean you’re subject to the same rules as industry sponsors—and even if you are not in a partnership for drug development, ethical and other obligations may limit your ability to tout procedures, drugs, and devices.